Vistagen Broadens PH80 Global Intellectual Property Portfolio with New Patents for the Treatment of Migraine
Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company, announced new patents for PH80, a non-systemic nasal spray aimed at treating migraines. These patents extend Vistagen's global intellectual property portfolio across Australia, Hong Kong, Japan, and Mexico, supplementing previously granted U.S. and EPO patents. The new patents are effective until 2040, with potential for extensions. PH80 is also being developed for menopause-related hot flashes and other conditions.
- Vistagen received multiple new patents for PH80, enhancing its global intellectual property portfolio.
- The patents cover Australia, Hong Kong, Japan, and Mexico, supplementing existing U.S. and EPO patents.
- Patents are effective until 2040, subject to extensions.
- None.
Insights
The issuance of new patents for Vistagen's PH80 nasal spray in multiple countries like Australia, Hong Kong, Japan and Mexico extends the company's intellectual property (IP) protection until at least 2040. This development significantly strengthens Vistagen's competitive position in these regions by preventing generic manufacturers from entering the market with similar products. Patents play a important role in safeguarding innovation and enabling companies to recoup research and development investments. By extending their IP portfolio, Vistagen also improves its leverage in potential licensing deals or partnerships, enhancing its long-term revenue prospects.
However, investors should note that while expanded IP protection is a positive step, it does not guarantee commercial success. The company must still successfully navigate clinical trials, regulatory approvals and market competition.
For retail investors, these new patents represent a form of risk mitigation, securing the company's future revenue streams in the event that PH80 becomes a commercial success.
Vistagen's PH80 is described as a non-systemic, hormone-free investigational pherine nasal spray targeting rapid-onset relief for migraines and other conditions. The non-systemic and hormone-free aspects are particularly noteworthy because they imply fewer systemic side effects, which often plague systemic migraine medications. This can be an appealing factor for both patients and healthcare providers, potentially enhancing market adoption if the product proves effective in clinical trials.
From a long-term perspective, the success of PH80 in clinical trials could disrupt the migraine treatment market by offering a novel, fast-acting option. However, investors should be cautious and follow ongoing clinical trial results closely, as the efficacy and safety of the treatment remain to be fully validated.
Understanding the unique mechanism of action and its potential advantages can be enlightening for investors, as it provides context for the company's claims and future potential.
The new patents complement previously granted PH80
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Australia : IP Australia issued a Notice of Allowance; -
Hong Kong : The Hong Kong Special Administrative Region – Intellectual Property Department issued Patent No. 40068177; -
Japan : The Japan Patent Office issued Patent No. 7476229; and -
Mexico : The Mexican Institute of Industrial Property issued a Notice of Allowance.
About PH80 Nasal Spray
PH80 is an investigational neuroactive pherine nasal spray with a novel neurocircuitry-focused mechanism of action (MOA) that is fundamentally differentiated from all currently approved treatment options for women’s health indications. PH80’s proposed MOA does not require systemic absorption or direct activity on neurons in the brain. Vistagen is developing PH80 as a potential new hormone-free treatment for the management of vasomotor symptoms (hot flashes) due to menopause, with additional potential in premenstrual dysphoric disorder, migraine, and dysmenorrhea.
About Pherines
Pherines are a novel class of synthetic neurocircuitry-focused drug candidates for psychiatric and neurological disorders. They are odorless and tasteless neuroactive steroids, delivered only intranasally, each with a differentiated mechanism of action (MOA) and safety profile from all currently approved drugs. Our neuroactive pherines rapidly activate olfactory system neurocircuitry to achieve therapeutic effects via nose-to-brain neural connections. Through these connections, pherines activate neural circuitry to specific brain regions that impact the neuroscience disorders we are targeting, without requiring systemic absorption or central nervous system (CNS) uptake. As a result of their novel non-systemic MOAs, our pherine drug candidates have demonstrated favorable and differentiated safety profiles in all clinical trials completed to date.
About Vistagen
Headquartered in
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen Therapeutics, Inc. (Vistagen or the Company) and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or development may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that the scope of protection and enforceability provided by any patents issued for any of the Company’s drug candidates, including PH80, will be sufficient to deter competition, or that any of the Company’s drug candidates, including PH80, will successfully replicate past preclinical studies and/or clinical trials, complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching, conducting and/or completing ongoing and planned nonclinical studies and clinical trials; the period over which the Company anticipates its available financial resources will fund its operating expense; the timing of completion of preclinical studies and clinical trials and related preparatory work required to apply for and maintain regulatory approval for any of our product candidates; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in
View source version on businesswire.com: https://www.businesswire.com/news/home/20240709110616/en/
Investors:
Mark A. McPartland
Vistagen Therapeutics
markmcp@vistagen.com
Media:
Caren Scannell
Vistagen Therapeutics
cscannell@vistagen.com
Source: Vistagen
FAQ
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